# K244043: AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou AllTest Biotech Co., Ltd.
- Decided: Feb 27, 2025 after 59 days
- Product code: NFT (Test, Amphetamine, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001178 (2000). 19 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233019: AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx, Hangzhou AllTest Biotech Co., Ltd. (2023) Summary page 7.

## Most influential descendants
- K250727: AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup (2025), 1 descendant of its own
- K260355: Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup (2026), 0 descendants of its own
- K252867: VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup (2025), 0 descendants of its own
- K252118: CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup (2025), 0 descendants of its own

## Indications for use
AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene, Fentanyl and 6- monoacetylmorphine in human urine at the cutoff concentrations of: Drug (Identifier) Cut-off level Amphetamine (AMP) 500 or 1000 ng/mL Buprenorphine (BUP) 10 ng/mL Secobarbital (BAR) 300 ng/mL Benzodiazepines (BZO) 300 ng/mL Cocaine (COC) 150 or 300 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL Methamphetamine (MET) 500 or 1000 ng/mL Methylenedioxymethamphetamine (MDMA) 500 ng/mL Morphine (MOP/OPI) 300 or 2000 ng/mL Methadone (MTD) 300 ng/mL Oxycodone (OXY) 100 ng/mL Phencyclidine (PCP) 25 ng/mL Nortriptyline (TCA) 1000 ng/mL Marijuana (THC) 50 ng/mL Tramadol (TRA) 100 ng/mL Propoxyphene (PPX) 300 ng/mL Fentanyl(FYL) 1 ng/mL 6-monoacetylmorphine (6-MAM) 10 ng/mL AllTest Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. AllTest Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene Fentanyl and 6-monoacetylmorphine in human urine at the cutoff concentrations of: Drug (Identifier) Calibrator Cut-off (ng/mL) Amphetamine (AMP) d-Amphetamine 500 or 1000 Buprenorphine (BUP) Buprenorphine 10 Secobarbital (BAR) Secobarbital 300 Benzodiazepines (BZO) Oxazepam 300 Cocaine (COC) Benzoylecgonine 150 or 300 2-ethylidene-1,5-dimethyl- 2-ethylidene-1,5-dimethyl- 300 3,3-diphenylpyrrolidine (EDDP) 3,3-diphenylpyrrolidine Methamphetamine (MET) d-Methamphetamine 500 or 1000 Methylenedioxymethamphetamine (MDMA) d,l-Methylenedioxymethamphetamine 500 Morphine (MOP/OPI) Morphine 300 or 2000 Methadone (MTD) Methadone 300 Oxycodone (OXY) Oxycodone 100 Phencyclidine (PCP) Phencyclidine 25 Nortriptyline (TCA) Nortriptyline 1000 Marijuana (THC) 1-nor-Δ9-THC-9 COOH 50 Tramadol (TRA) Tramadol 100 Propoxyphene (PPX) Propoxyphene 300 Fentanyl(FYL) Fentanyl 1 6-monoacetylmorphine (6-MAM) 6-monoacetylmorphine 10 AllTest Multi-Drug Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Source page: https://510kreport.com/device/K244043
Methodology: https://510kreport.com/methodology